WAKO DIRECT BILIRUBIN V

• K Number: K970986
• Device Name: WAKO DIRECT BILIRUBIN V
• Manufacturer: WAKO CHEMICALS, USA, INC.
• Date Cleared: 1997-05-07 ( 50 days)
• Product Code: CIG
• Regulation Number: 862.1110

Intended Use

Serum bilirubin measurement is widely used as a screening test for liver functions.

Device Description

Wako Total Bilirubin V is based on a chemical oxidation method, utilizing vanadate as an oxidizing agent, shows good correlation with conventional methods, practically no interference by coexistent serum substances, and is convenient ready-to-use liquid type reagent. When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH 3, direct bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the direct bilirubin concentration in the sample can be obtained by measuring the absorbance before and after the vanadate oxidation.

Predicate Devices

K912024/A

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a chemical oxidation method for measuring bilirubin, and there is no mention of AI, ML, or related concepts in the provided text.

Therapeutic

No.
The "Wako Total Bilirubin V" is described as a reagent used for measuring serum bilirubin, which is a diagnostic test. It identifies a condition (high bilirubin) but does not treat it.

Diagnostic

Yes
The device measures serum bilirubin, which is described as a "screening test for liver functions," indicating its use in diagnosing a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "ready-to-use liquid type reagent" and describes a "chemical oxidation method," indicating it is a physical reagent kit, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is "Serum bilirubin measurement is widely used as a screening test for liver functions." This clearly indicates the device is used to test a biological sample (serum) in vitro (outside the body) to provide information about a patient's health (liver function).
• Device Description: The description details a chemical method for analyzing a serum sample to determine bilirubin levels. This is a typical characteristic of an IVD.
• Performance Studies: The performance studies describe comparisons with a predicate assay using serum samples and evaluate metrics like correlation and linearity, which are standard for validating IVD performance.

The core function of the device is to analyze a biological sample (serum) in vitro to provide diagnostic information, which aligns perfectly with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Not Found

Product codes

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Device Description

When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH 3, direct bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the direct bilirubin concentration in the sample can be obtained by measuring the absorbance before and after the vanadate oxidation.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

In comparison studies against the predicate assay, a correlation coefficient of 0.997 and a regression equation y=1.003x + 0.09 was obtained with serum samples. Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is 0.03 mg/dL. The Wako Direct Bilirubin V assay is linear to 20 mg/dL.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K912024/A

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 862.1110 Bilirubin (total or direct) test system.

(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.

Summary

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K970986

Wako Chemicals USA, Inc. Vink 1600 Bellwood Road, Richmond, VA 23237 U.S.A. Telephone [phone] Telex 293208 WAKO UR(RCA) Facsimile [phone]

MAY - 7 1997

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510 (k) Summary of Safety and Effectiveness

Serum bilirubin measurement is widely used as a screening test for liver functions. The methods most widely used for determination of bilirubin oxidase enzymatic method4). However, these methods have disadvantages such as interference by coexistent serum substances unsatisfactory stability of reagents after preparation. Wako Total Bilirubin V is based on a chemical oxidation method, utilizing oxidizing agent, shows good correlation with vanadate as an conventional methods, practically no interference by coexistent serum substances, and is convenient ready-to-use liquid type reagent5).

When a sample is mixed with the reagent containing the detergent and the vanadate, at around pH 3, direct bilirubin in the sample is oxidized to biliverdin. This causes the absorbance of yellow, specific to bilirubin, to decrease. Therefore, the direct bilirubin concentration in the sample can be obtained by measuring the absorbance before and after the vanadate oxidation.

The safety and effectiveness of the Wako Direct Bilirubin V assay is demonstrated by its substantial equivalency to our previous Direct Bilirubin assay (510(k)#K912024/A). Both test systems are used to measure total bilirubin is serum. In comparison studies against the predicate assay, a correlation coefficient of 0.997 and a regression equation y=1.003x + 0.09 was obtained with serum samples. Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is 0.03 mg/dL. The Wako Direct Bilirubin V assay is linear to 20 mg/dL.

References

• Malloy H.T., Evelyn K.L. The determination of bilirubin with 1 • the photoelectric colorimetry. J.Biol.Chem.,199: 481-490, (1937) .
• Photometrische Cleghorn R.A. 2 . Jendrassik L. , bilirubinbestimmung. Biochem. Z., 289: 1-14, (1937).
• Michaelsson M. Bilirubin determination in serum and urine. 3 . Scand. J.Clin.Lab.Invest.,12(Suppl 56): 1-80, (1937).
• Murao S.,Tanaka N. A new enzyme "bilirubin oxidase" produced 4 . by Myrothecium varrucaria MT-1. Agric.Biol.Chem. 45: 2383-2384, (1981).
• and Tanimoto K. New method of measuring న్ . Tokuda K. serum bilirubin using vanadic acid. Jpn.Clin.Chem., 22(2), 116-122 (1993) .

LaTonya Mallory Wako Chemicals USA, Inc. April 30, 1997